Healthy IndividualsNCT01872091
Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy
A study testing cryotherapy by immersion in people with Healthy Individuals, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries and veins resulting in decreased blood flow. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- cryotherapy by immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals, age range: 18 - 30 years old
Who cannot join
- not present: previous circulatory, nervous or metabolic diseases, metal implants in areas to be studied; fracture on upper limb studied; history of pain or injury in the joints studied
- are not in menstrual period or a week before it
- not be making use of antipyretic drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rinaldo Roberto de Jesus Guirro
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy by Immersion of the Forearm
Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries and veins resulting in decreased blood flow.
Read the detailed description
Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries and veins resulting in decreased blood flow. Thus, this study aims to evaluate neuromuscular and biomechanical assess hemodynamic and autonomic cardiovascular, and investigate the occurrence of changes in conduction velocity due to the superficial blood cryotherapy by immersion of the forearm. The study will be conducted in 40 volunteers, female, between 18 and 30 years, university, healthy. They will be divided into two groups of 20 volunteers, the group immersion cryotherapy (GI) and control group (CG). For immersion cryotherapy group (GI), individuals will be the right arm to the elbow immersed in a container of water at 6°C ± 2°C for 15 minutes. In the control group (CG), volunteers will remain at rest with the right arm in the same position within a vessel containing water at a temperature indifferent for the same period of 15 minutes. The temperature analysis is performed using a infrared thermographer, muscular strength and synergism will be evaluated by a load cell connected to the electromyograph to examine muscle activation of wrist flexors and extensors, serratus anterior, upper and middle trapezius. The records beat to beat blood pressure and heart rate for cardiovascular autonomic and hemodynamic evaluation will be carried out by means of equipment and Finometer electrocardiogram, respectively, before and after application of cryotherapy. In turn, the data of blood flow velocity will be collected by means of Doppler Ultrasound. The results will be processed and analyzed using descriptive statistics, submitted to a linear regression model with mixed effects (fixed and random effects), with p≤0.05.
- Conditions
- Healthy Individuals
- Being tested
- cryotherapy by immersion, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy by immersionOther
Control groupOther
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy by immersion | Experimental | Cryotherapy group immersion (GI) composed of 20 volunteers, which will be subjected to immersion cryotherapy upper limb dominant in cold water (6°C ± 2°C), at the level of the elbow joint. Receives: Other: cryotherapy by immersion |
| Control group | Experimental | (CG) consisted of 20 volunteers, which will be submitted to immersion of the dominant upper limb in water at room temperature indifferent to the level of the elbow joint; Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the strength and muscle synergism after cryotherapy immersion
The objective of this study is to Evaluate the strength and muscle synergism between wrist flexors and extensors after forearm immersion cryotherapy. Testing grip strength will be carried out 3 times in a row, with 4 seconds of maximum voluntary isometric contraction, with a 1 minute interval between them; before, immediately after, 25 minutes and 50 minutes after immersion. Strength evaluation is conducted using a load cell. Concurrent with this test, the signal will be collected electromyographic extensor and flexor wrist, upper and middle trapezius fibers and anterior serratus.
Measured: 2 years
Secondary outcomes (1)
Blood flow velocity before and after immersion of the forearm cryotherapy
The data of blood flow velocity will be collected through the portable Doppler ultrasound wave continues. Immediately before the strength tests will be collected the data from the radial artery blood flow (3 times per collection), so there are no changes due to muscular work required in the handgrip test.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Rinaldo Guirro, Professor, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872091
- Sponsor's protocol ID
- U1111-1143-3579
- Status last verified
- Jul 2017
- First submitted
- 27 May 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy by Immersion of the Forearm
- ClinicalTrials.gov ID
- NCT01872091
- Acronym / sponsor ID
- U1111-1143-3579
- Conditions
- Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries and veins resulting in decreased blood flow.
Detailed description
Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries and veins resulting in decreased blood flow. Thus, this study aims to evaluate neuromuscular and biomechanical assess hemodynamic and autonomic cardiovascular, and investigate the occurrence of changes in conduction velocity due to the superficial blood cryotherapy by immersion of the forearm. The study will be conducted in 40 volunteers, female, between 18 and 30 years, university, healthy. They will be divided into two groups of 20 volunteers, the group immersion cryotherapy (GI) and control group (CG). For immersion cryotherapy group (GI), individuals will be the right arm to the elbow immersed in a container of water at 6°C ± 2°C for 15 minutes. In the control group (CG), volunteers will remain at rest with the right arm in the same position within a vessel containing water at a temperature indifferent for the same period of 15 minutes. The temperature analysis is performed using a infrared thermographer, muscular strength and synergism will be evaluated by a load cell connected to the electromyograph to examine muscle activation of wrist flexors and extensors, serratus anterior, upper and middle trapezius. The records beat to beat blood pressure and heart rate for cardiovascular autonomic and hemodynamic evaluation will be carried out by means of equipment and Finometer electrocardiogram, respectively, before and after application of cryotherapy. In turn, the data of blood flow velocity will be collected by means of Doppler Ultrasound. The results will be processed and analyzed using descriptive statistics, submitted to a linear regression model with mixed effects (fixed and random effects), with p≤0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryotherapy by immersion | Experimental | Other: cryotherapy by immersionCryotherapy group immersion (GI) composed of 20 volunteers, which will be subjected to immersion cryotherapy upper limb dominant in cold water (6°C ± 2°C), at the level of the elbow joint. |
| Control group | Experimental | Other: Control group(CG) consisted of 20 volunteers, which will be submitted to immersion of the dominant upper limb in water at room temperature indifferent to the level of the elbow joint; |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy individuals, age range: 18 - 30 years old
Key exclusion criteria (3 listed)
- not present: previous circulatory, nervous or metabolic diseases, metal implants in areas to be studied; fracture on upper limb studied; history of pain or injury in the joints studied
- are not in menstrual period or a week before it
- not be making use of antipyretic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapy by immersion | Other | cryotherapy by immersion |
| Control group | Other | Control group |
Primary outcome
Evaluate the strength and muscle synergism after cryotherapy immersion
Time frame: 2 years
The objective of this study is to Evaluate the strength and muscle synergism between wrist flexors and extensors after forearm immersion cryotherapy. Testing grip strength will be carried out 3 times in a row, with 4 seconds of maximum voluntary isometric contraction, with a 1 minute interval between them; before, immediately after, 25 minutes and 50 minutes after immersion. Strength evaluation is conducted using a load cell. Concurrent with this test, the signal will be collected electromyographic extensor and flexor wrist, upper and middle trapezius fibers and anterior serratus.
1 secondary outcome
Blood flow velocity before and after immersion of the forearm cryotherapy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinaldo Guirro, Professor study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy by immersion in people with Healthy Individuals, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the strength and muscle synergism after cryotherapy immersion (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.